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| Name | Class |
|---|---|
| NeuroVision | INDUSTRY |
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The purpose of this study is to describe the impact of adding intraoperative video laryngoscopy (IOVL) to intraoperative laryngeal nerve monitoring (IOLNM) during neck procedures when IOLNM is routinely used, including thyroidectomy and re-operative parathyroidectomy. Specifically, the study team seeks to assess how frequently the use of IOVL provided confirmatory or additional information that may affect surgeon decision-making when IOLNM alone is ambiguous, or when there is equipment malfunction or failure. The IOVL is a disposable, otherwise standard fiberoptic laryngoscope (Larynxview, Neurovision Medical, Ventura CA) that is inserted alongside the endotracheal tube following intubation for surgical procedures. It allows assessment of vocal cord movement in response to nerve stimulation. Currently, the use of IOLNM is based on audio cues, and visual assessment of external laryngeal muscle movement during surgery in response to stimulation, but no direct assessment of vocal cord movement is routinely possible. This information can be ambiguous and subject to judgement of the surgeon. The addition of IOVL provides direct assessment to vocal cord movement in response to stimulus, and may be useful in light of ambiguous IOLNM data, or limited visualization of external laryngeal muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Video Laryngoscopy | Experimental | Participants undergoing neck procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Video Laryngoscopy | Device | The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value <100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value >100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve. | up to 3 months post-resection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Owen, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Queens | Long Island City | New York | 11102 | United States | ||
| Mount Sinai Beth Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraoperative Video Laryngoscopy | Participants undergoing neck procedures Intraoperative Video Laryngoscopy: The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures. Glycopyrrolate: 0.004mg/kg as per routine prior to intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraoperative Video Laryngoscopy | Participants undergoing neck procedures Intraoperative Video Laryngoscopy: The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures. Glycopyrrolate: 0.004mg/kg as per routine prior to intubation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value <100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value >100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve. | Posted | Count of Units | nerves at risk | up to 3 months post-resection | nerves at risk | nerves at risk |
|
3 months
Definition of adverse event from 21 CFR 312.32 (a): any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intraoperative Video Laryngoscopy | Participants undergoing neck procedures Intraoperative Video Laryngoscopy: The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures. Glycopyrrolate: 0.004mg/kg as per routine prior to intubation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tracheostomy | Injury, poisoning and procedural complications | 21 CFR 312.32 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transected nerve intraoperatively | Injury, poisoning and procedural complications | 21 CFR 312.32 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Steinmetz | Icahn School of Medicine at Mount Sinai | 646-831-5950 | dsteinmetz0@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2022 | Sep 29, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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All patients enrolled in the study will be in a single group.
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|
| Glycopyrrolate | Drug | 0.004mg/kg as per routine prior to intubation |
|
| New York |
| New York |
| 10003 |
| United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Mount Sinai St. Luke's | New York | New York | 10025 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| History of Thyroiditis | Count of Participants | Participants |
|
| Thyroid Weight | Mean | Full Range | grams |
|
| Thyroid Size | Mean | Full Range | cm |
|
| Indication for surgery | Count of Participants | Participants |
|
| Type of surgery | Count of Participants | Participants |
|
| OG000 | Intraoperative Video Laryngoscopy | 75 participants (108 nerves at risk) undergoing thyroid lobectomy or total thyroidectomy for benign and malignant disease with concurrent use of intraoperative video laryngeal monitoring and intermittent standard EMG monitoring, using the Nerveana nerve monitoring system. |
|
|
| 0 |
| 75 |
| 1 |
| 75 |
| 2 |
| 75 |
| reintubation and a tracheostomy immediately postoperatively | Injury, poisoning and procedural complications | 21 CFR 312.32 | Systematic Assessment |
|
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| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |